Suffolk Reporter

There were six companies in cities associated with Suffolk County that received FDA citations as a result of six inspections conducted in the county over the first quarter of 2024, according to reports from the U.S. Food and Drug Administration (FDA).

This is a 25% decrease from the number of companies cited in the previous quarter.

The citations in the county include:

• You did not determine whether you met established product specifications for identity and composition of the finished batch of the dietary supplement.
• You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.
• Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size and suitably located to facilitate operations for its intended use.

Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the .

All of the companies cited should take voluntary actions to correct their managing operations.

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.

Company Name	Area of Business	Inspection Date	Issue Cited
Botticelli Foods, LLC	Food and Cosmetics	02/27/2024	Develop FSVP
Botticelli Foods, LLC	Food and Cosmetics	02/27/2024	Hazard analysis biological, chemical, physical
Botticelli Foods, LLC	Food and Cosmetics	02/27/2024	Supplier verification assurance
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Scheduled process
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Visible code
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Raw materials, packaging, finished product
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Maintenance of processing and production records
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Processing and production - required information
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Personnel
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Plant construction and design
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Pest control
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Hazard analysis - Identification of hazard
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Allergen preventive controls - Implement
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Sanitation preventive controls - Implement
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Process preventive controls - Appropriate (Adequate)
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Sanitation preventive controls - Appropriate (Adequate)
Elwood International, Inc.	Food and Cosmetics	03/08/2024	Supply-chain program - Assurance (Adequate)
RMA Long Island IVF	Biologics	02/09/2024	Testing, screening, donor eligibility procedures
RMA Long Island IVF	Biologics	02/09/2024	Responsible person to determine, document
RMA Long Island IVF	Biologics	02/09/2024	Accurate, indelible, legible
Radienz Living, LLC	Drugs	01/11/2024	Equipment Design, Size and Location
Radienz Living, LLC	Drugs	01/11/2024	Written procedures not established/followed
Radienz Living, LLC	Drugs	01/11/2024	Computer control of master formula records
Radienz Living, LLC	Drugs	01/11/2024	Control procedures to monitor and validate performance
Radienz Living, LLC	Drugs	01/11/2024	Storage under appropriate conditions
Radienz Living, LLC	Drugs	01/11/2024	Batch production and Batch Control Record Requirements
The Bountiful Company	Food and Cosmetics	03/18/2024	Specifications met - identity, purity, strength, composition
The Bountiful Company	Food and Cosmetics	03/18/2024	Component - verify identity, dietary ingredient
U. S. Department of Veterans Affairs, Northport VA Medical Center	Biologics	01/09/2024	Establish, maintain and follow manufacturing SOPs
U. S. Department of Veterans Affairs, Northport VA Medical Center	Biologics	01/09/2024	Required records